Trial Outcomes & Findings for Safety and Tolerability of the Ophthalmic Solution PRO-179 Compared With Travatan® (NCT NCT03965052)
NCT ID: NCT03965052
Last Updated: 2019-12-12
Results Overview
primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent. it will be evaluated by the number of reported cases per group.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
during the 14 days of evaluation, including the safety call (day 14).
Results posted on
2019-12-12
Participant Flow
Participant milestones
| Measure |
PRO-179
Dosage: 1 drop every 24 hours, at night, in both eyes.
PRO 179: o Generic name: Travoprost
* Distinctive denomination: Bristrio® (PRO-179)
* Active principles: Travoprost 0.004%.
* Pharmaceutical form: Ophthalmic solution
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Sophia Laboratories, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene.
|
Travatan®
Dosage: 1 drop every 24 hours, at night, in both eyes.
Travatan 0.004 % Ophthalmic Solution: o Generic name: Travoprost
* Distinctive denomination: Travatan®
* Active ingredients: Travoprost 0.004%
* Pharmaceutical form: Ophthalmic solution.
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Alcon Laboratories Inc.
* Description of the solution: transparent solution, free of visible particles.
* Consult information to prescribe.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
PRO-179
Dosage: 1 drop every 24 hours, at night, in both eyes.
PRO 179: o Generic name: Travoprost
* Distinctive denomination: Bristrio® (PRO-179)
* Active principles: Travoprost 0.004%.
* Pharmaceutical form: Ophthalmic solution
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Sophia Laboratories, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene.
|
Travatan®
Dosage: 1 drop every 24 hours, at night, in both eyes.
Travatan 0.004 % Ophthalmic Solution: o Generic name: Travoprost
* Distinctive denomination: Travatan®
* Active ingredients: Travoprost 0.004%
* Pharmaceutical form: Ophthalmic solution.
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Alcon Laboratories Inc.
* Description of the solution: transparent solution, free of visible particles.
* Consult information to prescribe.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Safety and Tolerability of the Ophthalmic Solution PRO-179 Compared With Travatan®
Baseline characteristics by cohort
| Measure |
PRO-179
n=12 Participants
Dosage: 1 drop every 24 hours, at night, in both eyes.
PRO 179: o Generic name: Travoprost
* Distinctive denomination: Bristrio® (PRO-179)
* Active principles: Travoprost 0.004%.
* Pharmaceutical form: Ophthalmic solution
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Sophia Laboratories, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene.
|
Travatan®
n=12 Participants
Dosage: 1 drop every 24 hours, at night, in both eyes.
Travatan 0.004 % Ophthalmic Solution: o Generic name: Travoprost
* Distinctive denomination: Travatan®
* Active ingredients: Travoprost 0.004%
* Pharmaceutical form: Ophthalmic solution.
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Alcon Laboratories Inc.
* Description of the solution: transparent solution, free of visible particles.
* Consult information to prescribe.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.2 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
24.7 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
26.3 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latin
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: during the 14 days of evaluation, including the safety call (day 14).Population: the analysis was carried out by intention to treat (ITT)
primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent. it will be evaluated by the number of reported cases per group.
Outcome measures
| Measure |
PRO-179
n=12 Participants
Dosage: 1 drop every 24 hours, at night, in both eyes.
PRO 179: o Generic name: Travoprost
* Distinctive denomination: Bristrio® (PRO-179)
* Active principles: Travoprost 0.004%.
* Pharmaceutical form: Ophthalmic solution
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Sophia Laboratories, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene.
|
Travatan®
n=12 Participants
Dosage: 1 drop every 24 hours, at night, in both eyes.
Travatan 0.004 % Ophthalmic Solution: o Generic name: Travoprost
* Distinctive denomination: Travatan®
* Active ingredients: Travoprost 0.004%
* Pharmaceutical form: Ophthalmic solution.
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Alcon Laboratories Inc.
* Description of the solution: transparent solution, free of visible particles.
* Consult information to prescribe.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
10 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: will be evaluated at the end of the treatment, at the final visit (day 11)Population: the analysis was per protocol
It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100).The Eye comfort index contains items that focus on the discomfort associated with alterations of the ocular surface.(0: None discomfort, 100: high discomfort).
Outcome measures
| Measure |
PRO-179
n=11 Participants
Dosage: 1 drop every 24 hours, at night, in both eyes.
PRO 179: o Generic name: Travoprost
* Distinctive denomination: Bristrio® (PRO-179)
* Active principles: Travoprost 0.004%.
* Pharmaceutical form: Ophthalmic solution
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Sophia Laboratories, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene.
|
Travatan®
n=12 Participants
Dosage: 1 drop every 24 hours, at night, in both eyes.
Travatan 0.004 % Ophthalmic Solution: o Generic name: Travoprost
* Distinctive denomination: Travatan®
* Active ingredients: Travoprost 0.004%
* Pharmaceutical form: Ophthalmic solution.
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Alcon Laboratories Inc.
* Description of the solution: transparent solution, free of visible particles.
* Consult information to prescribe.
|
|---|---|---|
|
Eye Comfort Index
|
26.61 score on a scale
Standard Deviation 11.3
|
28.97 score on a scale
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment, at the final visit (day 11)Population: The analysis was per protocol
The epithelial defects will be evaluated by means of two stains, lissamine green and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.
Outcome measures
| Measure |
PRO-179
n=22 eyes
Dosage: 1 drop every 24 hours, at night, in both eyes.
PRO 179: o Generic name: Travoprost
* Distinctive denomination: Bristrio® (PRO-179)
* Active principles: Travoprost 0.004%.
* Pharmaceutical form: Ophthalmic solution
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Sophia Laboratories, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene.
|
Travatan®
n=24 eyes
Dosage: 1 drop every 24 hours, at night, in both eyes.
Travatan 0.004 % Ophthalmic Solution: o Generic name: Travoprost
* Distinctive denomination: Travatan®
* Active ingredients: Travoprost 0.004%
* Pharmaceutical form: Ophthalmic solution.
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Alcon Laboratories Inc.
* Description of the solution: transparent solution, free of visible particles.
* Consult information to prescribe.
|
|---|---|---|
|
Number of Eyes With Epithelial Defects by Grade
Green lissamine grade 0
|
22 eyes
|
23 eyes
|
|
Number of Eyes With Epithelial Defects by Grade
Green lissamine grade 1
|
0 eyes
|
1 eyes
|
|
Number of Eyes With Epithelial Defects by Grade
Green lissamine grade 2
|
0 eyes
|
0 eyes
|
|
Number of Eyes With Epithelial Defects by Grade
Green lissamine grade 3
|
0 eyes
|
0 eyes
|
|
Number of Eyes With Epithelial Defects by Grade
Green lissamine grade 4
|
0 eyes
|
0 eyes
|
|
Number of Eyes With Epithelial Defects by Grade
Fluorescein grade 0
|
20 eyes
|
20 eyes
|
|
Number of Eyes With Epithelial Defects by Grade
Fluorescein grade 1
|
2 eyes
|
4 eyes
|
|
Number of Eyes With Epithelial Defects by Grade
Fluorescein grade 2
|
0 eyes
|
0 eyes
|
|
Number of Eyes With Epithelial Defects by Grade
Fluorescein grade 3
|
0 eyes
|
0 eyes
|
|
Number of Eyes With Epithelial Defects by Grade
Fluorescein grade 4
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment, at the final visit (day 11)Population: the analysis was per protocol
The visual capacity variable will be reported using as a unit of measure a fraction, this is taken from a visual test with the Snellen primer, it is a Nominal type variable. where the optimal vision is 20/20 and the worst vision is 20/200, higher values represent a worst vision. The result of the Snellen chart has equivalents in an international logarithmic system called Logmar (logarithm of the minimum angle of resolution) for better understanding. Snellen Scale: 20/200, 20/100, 20/50, 20/40, 20/30, 20/25, 20/20, 20/15, 20/12, 20/10. Snellen / LogMAR equivalences: 20/200= 1.0, 20/100=0.7, 20/50=0.4, 20/40=0.3, 20/30=0.2, 20/25=0.1, 20/20=0.0, 20/15=0.13, 20/12=0.2, 20/10=-0.3, etc.
Outcome measures
| Measure |
PRO-179
n=11 Participants
Dosage: 1 drop every 24 hours, at night, in both eyes.
PRO 179: o Generic name: Travoprost
* Distinctive denomination: Bristrio® (PRO-179)
* Active principles: Travoprost 0.004%.
* Pharmaceutical form: Ophthalmic solution
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Sophia Laboratories, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene.
|
Travatan®
n=12 Participants
Dosage: 1 drop every 24 hours, at night, in both eyes.
Travatan 0.004 % Ophthalmic Solution: o Generic name: Travoprost
* Distinctive denomination: Travatan®
* Active ingredients: Travoprost 0.004%
* Pharmaceutical form: Ophthalmic solution.
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Alcon Laboratories Inc.
* Description of the solution: transparent solution, free of visible particles.
* Consult information to prescribe.
|
|---|---|---|
|
Visual Ability
|
0.0 LogMAR
Standard Deviation 0
|
0.0 LogMAR
Standard Deviation 0
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment, at the final visit (day 11)Population: the analysis was per protocol
Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very Light / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological.
Outcome measures
| Measure |
PRO-179
n=22 eyes
Dosage: 1 drop every 24 hours, at night, in both eyes.
PRO 179: o Generic name: Travoprost
* Distinctive denomination: Bristrio® (PRO-179)
* Active principles: Travoprost 0.004%.
* Pharmaceutical form: Ophthalmic solution
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Sophia Laboratories, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene.
|
Travatan®
n=24 eyes
Dosage: 1 drop every 24 hours, at night, in both eyes.
Travatan 0.004 % Ophthalmic Solution: o Generic name: Travoprost
* Distinctive denomination: Travatan®
* Active ingredients: Travoprost 0.004%
* Pharmaceutical form: Ophthalmic solution.
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Alcon Laboratories Inc.
* Description of the solution: transparent solution, free of visible particles.
* Consult information to prescribe.
|
|---|---|---|
|
Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade
Normal (0)
|
14 eyes
|
16 eyes
|
|
Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade
Very mild (1)
|
2 eyes
|
2 eyes
|
|
Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade
Mild (2)
|
6 eyes
|
6 eyes
|
|
Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade
Moderate (3)
|
0 eyes
|
0 eyes
|
|
Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade
Severe (4)
|
0 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: will be evaluated at the end of the treatment, at the final visit (day 11)Population: the analysis was per protocol
The chemosis will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent.
Outcome measures
| Measure |
PRO-179
n=22 eyes
Dosage: 1 drop every 24 hours, at night, in both eyes.
PRO 179: o Generic name: Travoprost
* Distinctive denomination: Bristrio® (PRO-179)
* Active principles: Travoprost 0.004%.
* Pharmaceutical form: Ophthalmic solution
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Sophia Laboratories, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene.
|
Travatan®
n=24 eyes
Dosage: 1 drop every 24 hours, at night, in both eyes.
Travatan 0.004 % Ophthalmic Solution: o Generic name: Travoprost
* Distinctive denomination: Travatan®
* Active ingredients: Travoprost 0.004%
* Pharmaceutical form: Ophthalmic solution.
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Alcon Laboratories Inc.
* Description of the solution: transparent solution, free of visible particles.
* Consult information to prescribe.
|
|---|---|---|
|
Number of Eyes of Chemosis
|
0 eyes
|
0 eyes
|
OTHER_PRE_SPECIFIED outcome
Timeframe: will be evaluated at the end of the treatment, at the final visit (day 11)Population: the analysis was per protocol
the intraocular pressure will be evaluated by means of the Goldman applanation tonometry whose unit of measurement is millimeters of mercury (mmHg), it is a continuous variable and its normality range is between 11 - 21 mmHg
Outcome measures
| Measure |
PRO-179
n=22 eyes
Dosage: 1 drop every 24 hours, at night, in both eyes.
PRO 179: o Generic name: Travoprost
* Distinctive denomination: Bristrio® (PRO-179)
* Active principles: Travoprost 0.004%.
* Pharmaceutical form: Ophthalmic solution
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Sophia Laboratories, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene.
|
Travatan®
n=24 eyes
Dosage: 1 drop every 24 hours, at night, in both eyes.
Travatan 0.004 % Ophthalmic Solution: o Generic name: Travoprost
* Distinctive denomination: Travatan®
* Active ingredients: Travoprost 0.004%
* Pharmaceutical form: Ophthalmic solution.
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Alcon Laboratories Inc.
* Description of the solution: transparent solution, free of visible particles.
* Consult information to prescribe.
|
|---|---|---|
|
Changes in Intraocular Pressure
|
11.95 mmHg
Standard Deviation 1.6
|
10.71 mmHg
Standard Deviation 1.5
|
Adverse Events
PRO-179
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Travatan®
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PRO-179
n=12 participants at risk
Dosage: 1 drop every 24 hours, at night, in both eyes.
PRO 179: o Generic name: Travoprost
* Distinctive denomination: Bristrio® (PRO-179)
* Active principles: Travoprost 0.004%.
* Pharmaceutical form: Ophthalmic solution
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Sophia Laboratories, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene.
|
Travatan®
n=12 participants at risk
Dosage: 1 drop every 24 hours, at night, in both eyes.
Travatan 0.004 % Ophthalmic Solution: o Generic name: Travoprost
* Distinctive denomination: Travatan®
* Active ingredients: Travoprost 0.004%
* Pharmaceutical form: Ophthalmic solution.
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Alcon Laboratories Inc.
* Description of the solution: transparent solution, free of visible particles.
* Consult information to prescribe.
|
|---|---|---|
|
Eye disorders
ocular hypotony
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
0.00%
0/12 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
Other adverse events
| Measure |
PRO-179
n=12 participants at risk
Dosage: 1 drop every 24 hours, at night, in both eyes.
PRO 179: o Generic name: Travoprost
* Distinctive denomination: Bristrio® (PRO-179)
* Active principles: Travoprost 0.004%.
* Pharmaceutical form: Ophthalmic solution
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Sophia Laboratories, S.A. of C.V.
* Description of the solution: transparent solution, free of visible particles.
* Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene.
|
Travatan®
n=12 participants at risk
Dosage: 1 drop every 24 hours, at night, in both eyes.
Travatan 0.004 % Ophthalmic Solution: o Generic name: Travoprost
* Distinctive denomination: Travatan®
* Active ingredients: Travoprost 0.004%
* Pharmaceutical form: Ophthalmic solution.
* Presentation: multi-dose dropper bottle, 2.5 milliliters.
* Prepared by: Alcon Laboratories Inc.
* Description of the solution: transparent solution, free of visible particles.
* Consult information to prescribe.
|
|---|---|---|
|
Eye disorders
ocular burning
|
33.3%
4/12 • Number of events 4 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
50.0%
6/12 • Number of events 6 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
|
Nervous system disorders
headache
|
0.00%
0/12 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
|
Eye disorders
eye pain
|
16.7%
2/12 • Number of events 2 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
16.7%
2/12 • Number of events 2 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
|
Eye disorders
eyelid pain
|
0.00%
0/12 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
|
Eye disorders
photophobia
|
16.7%
2/12 • Number of events 2 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
|
Eye disorders
ocular hypotony
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
|
Eye disorders
eyelid swelling
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
|
Eye disorders
tearing
|
0.00%
0/12 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
16.7%
2/12 • Number of events 2 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
|
Eye disorders
red eye
|
83.3%
10/12 • Number of events 10 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
75.0%
9/12 • Number of events 9 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
|
Eye disorders
eye itching
|
16.7%
2/12 • Number of events 2 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
25.0%
3/12 • Number of events 3 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
|
Eye disorders
Eye discharge
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
0.00%
0/12 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
|
Eye disorders
foreign body sensation
|
0.00%
0/12 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
|
General disorders
Dry eye
|
33.3%
4/12 • Number of events 4 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
25.0%
3/12 • Number of events 3 • Adverse events were evaluated for about 2 months and one week until the last follow-up call of the last subject.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator undertakes not to publish or communicate data collected from the study, unless there is prior written agreement of Laboratorios Sophia, S.A. from C.V.
- Publication restrictions are in place
Restriction type: OTHER